- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01362023
Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2 (EDAL2)
September 28, 2021 updated by: Rosa Sola, University Rovira i Virgili
A Primary-school-based Study to Reduce Prevalence of Childhood Obesity in Terres de l'Ebre (Catalunya (Spain) - EDAL-Educació en Estils Saludables de Vida alimentació-2: Study Protocol for a Randomized Controlled Trial
Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity.
As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university students acting as "health promoting agents" (HPA) on the prevalence of obesity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Initial pupil enrollment and continued for 3 years.
Study Type
Interventional
Enrollment (Actual)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tarragona
-
Amposta, Tarragona, Spain, Terres de l'Ebre Catalunya
- Spain
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- In the intervention group, all children of the selected classroom are exposed to the intervention.
- The data a will collected on all the children, but only the data from individuals (and their parents) who provided informed consent are included in the final analyses.
- Name, gender, date and place of birth are recorded at the start of the program, while weight, height, body mass index (BMI) and waist circumference variables (identified set of anthropometric measures) are recorded in each of the 3 academic years of the study.
Exclusion Criteria:
- No adequate age
- Lack of inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control
Control pupils follow their usual activities
|
|
Experimental: lifestyle counseling
In 3 academic years, the intervention program consisted of three components:
In each of 12 activities (1 h/activity), the classroom practice consisted of three components:
|
In 3 academic years, the intervention program consisted of three components:
In each of 12 activities (1 h/activity), the classroom practice consisted of three components:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in prevalence of obesity
Time Frame: Changes from baseline in prevalence of obesity at 3 academic years
|
Primary outcomes include obesity (BMI ≥95th percentile) and overweight (BMI ≥85th percentile) We will analyzed obesity and overweight and a measure of thinness according to the Cole criteria as well as other measures of adiposity such as BMI z score and waist circumference.
The numbers of subjects having a particular dietary habit are expressed as percentages of the total number of individuals being evaluated
|
Changes from baseline in prevalence of obesity at 3 academic years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Montse Giralt, Md, PhD, Universitat Rovira i Virgili, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
May 23, 2011
First Submitted That Met QC Criteria
May 26, 2011
First Posted (Estimate)
May 27, 2011
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yes (OTHER: Beijing 302 Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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